To Evaluate the Safety, Efficacy, and Pharmacokinetics of Intravesical Instiliations of Disitamab Vedotin in Patients With High-risk Non-muscular Invasive Bladder Cancer (NMIBC) That Express HER2
Disitamab Vedotin for injection: Intravesical instiliations into the bladder
Study summary
The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics of intravesical instiliations of Disitamab Vedotin in patients with high-risk non-muscular invasive bladder cancer (NMIBC) that express HER2
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
1. Voluntary consent to participate in the study and signed the informed consent form.
2. Male or female, age 18-75 years (including both).
3. Histologic confirmed non-muscle invasive bladder urothelial carcinoma (NMIBC), and the risk group met the high-risk (including very high-risk) group.
Note: High-risk NMIBC is a high-grade / G3 tumor meeting any of the following:
a.Carcinoma in situ (CIS) b. T1 stage c. diameter\>3cm d.Multiple tumors, or recurrent tumors.
4. Absence of resectable disease(Ta and/or T1 disease) after transurethral resection (TURBT) procedures (residual CIS acceptable;
5. The urologist assessed that radical surgery for bladder cancer was not suitable or the subject refused radical surgery for bladder cancer.
6. Tumor tissue samples were detected by immunohistochemistry (IHC) to satisfy HER2 expression of 1+, 2+ or 3+.
7. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
8. Adequate heart, bone marrow, liver, kidney and coagulation function
Exclusion Criteria:
* 1\. Invasive bladder cancer (T2 and above) and / or with regional lymph node and distant metastasis.
2\. Combined urothelial carcinoma outside the bladder (i. e., urethra, ureter or renal pelvis).
3\. Any other antitumor therapy received within 4 weeks before study administration, .
4 Subjects plan to undergo major surgery during the study or within 4 weeks before the first dose.
5, Known allergic to DV and its components or to any excipients.
Primary outcome measure(s)
Incidence of dose-limiting toxicity(DLT) (Phase I) — Approximately 21 days
Incidence of Adverse event (Phase I) — Approximately 1 years According to the NCI CTCAE V5.0, to evaluate safety including adverse event rate and adverse event grade
Recommended Phase II Dose(RP2D) — Approximately 21 days Assessed based on the Incidence of DLT
Maximum Tolerated Dosage(MTD) — Approximately 21 days Assessed based on the Incidence of DLT
Trial sites (6)
Facility
City
Region
Status
Sun Yat-sen Memorial Hospital,SunYat-sen University
Guangzhou
Guangdong
Recruiting
Tongji Hospital
Wuhan
Hubei
Not Yet Recruiting
Hunan Cancer hospital
Changsha
Hunan
Recruiting
The first affiliated hospital with nanjing medical universtity
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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